(14 days)
The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices such as Siemens SV300™ ventilator, Baxter Vigilance™ blood gas/continuous cardiac output monitor, Siemens SV900™ ventilator, Puritan Bennett 7200™ ventilator, and the Draeger Evita IITM, Draeger Evita IV™ and Draeger Babylog™ ventilators that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.
The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter is indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that the Siemens SV300™ ventilator, Baxter Vigilance™ blood gas/continuous cardiac output monitor, Siemens SV900™ ventilator, Draeger Evita II™, Evita IVTM, and Draeger Babylog™ ventilators, and Puritan Bennett 7200™ ventilator should be connected to the Siemens SC9000/SC9015 Bedside Monitor for display.
The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generated by third party devices (e.g. ventilators, SvO2 devices and infusion pumps) into a common format per the IEEE 1073 Medical Information Protocol and transmits this data to the Siemens SC9000/SC9015 Bedside Monitor. Attachment cables specific to third party devices are offered as accessories.
The provided text describes a 510(k) amendment for the Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter. This document is a regulatory submission for a device that acts as an interface between third-party medical devices (like ventilators and blood gas monitors) and the Siemens SC9000/SC9015 Bedside Monitor.
Based on the information provided, this is a regulatory filing for a protocol converter (an interface device) and not a medical device that diagnoses or treats a condition and thus does not involve clinical effectiveness studies, acceptance criteria, or performance data in the same way a diagnostic or therapeutic device would. The submission focuses on substantial equivalence to a predicate device.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies are not applicable to the nature of this particular device and its regulatory filing.
However, I can extract the relevant information and explain why other sections are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the traditional sense for this device. The regulatory submission focuses on demonstrating substantial equivalence in terms of intended use, operating environment, and technical specifications as a protocol converter, not on clinical performance metrics like sensitivity, specificity, or accuracy. The acceptance criteria would primarily relate to successful data conversion and transmission, which is assessed through non-clinical functional testing rather than clinical trials. The document explicitly states "Assessment of clinical performance data for equivalence: Not applicable."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Transforms data per IEEE 1073 Medical Information Protocol | Complies with IEEE 1073.3.1 and 1073.4.1 Standards |
| Transmits data to Siemens SC9000/SC9015 Bedside Monitor correctly | Functional as a protocol converter as per intended use |
| Connects specified third-party devices | Intended to connect listed ventilators and blood gas monitor |
| No adverse effects on patient safety or device functionality | Substantially equivalent to predicate, implying safety |
2. Sample size used for the test set and the data provenance
Not Applicable. As a protocol converter that facilitates data transfer, there isn't a "test set" of patient data in the clinical sense for evaluating diagnostic or therapeutic accuracy. The testing would be functional and engineering-based to ensure correct data conversion and transmission. The document doesn't detail any specific sample size for functional testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. "Ground truth" in the context of clinical accuracy (e.g., disease presence) is not relevant for this device. The ground truth for this protocol converter would be the accurate transmission of data, which is typically verified through engineering validation and testing by qualified technical personnel, not clinical experts establishing disease ground truth.
4. Adjudication method for the test set
Not Applicable. Since there is no "test set" of clinical cases requiring ground truth establishment by clinical experts, there is no adjudication method described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This device is a hardware/software interface for data transfer, not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are irrelevant to its function and regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a protocol converter. It's a "standalone" device in the sense that it operates as an interface, but its performance is measured by its ability to correctly convert and transmit data, not by clinical diagnostic accuracy in a standalone algorithm context. There is no algorithm performance to assess in the typical AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. For this device, "ground truth" would relate to the correctness of data conversion and transmission according to the specified protocols (e.g., IEEE 1073). This is established through technical specifications and validation testing, not clinical findings or outcomes data.
8. The sample size for the training set
Not Applicable. This document pertains to a protocol converter, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set, this question is not relevant.
Summary of Relevant Information from the Document:
- Device Type: Medical Information Bus (MIB) Protocol Converter.
- Purpose: Transforms data from third-party devices (e.g., ventilators, SvO2 devices, infusion pumps) into IEEE 1073 Medical Information Protocol format and transmits it to the Siemens SC9000/SC9015 Bedside Monitor for display.
- Intended Use Environment: OR or ICU, connecting to specified ventilators and blood gas monitors.
- Predicate Device: Hewlett-Packard Model M1032A Vuelink Interface Plug In Module (K923682).
- Equivalence Claim: Substantial equivalence based on intended use, technology, and adherence to relevant standards.
- Compliance Standards: IEEE 1073.3.1 - 1994 (Transport Profile - Connector Mode) and 1073.4.1 - 1994 (Physical Layer Interface - Cable Conn).
- Clinical Data: Explicitly stated as "Not applicable" for equivalence assessment.
- Testing Information: The submission states "Assessment of non-clinical performance data for equivalence" was done, implying functional and engineering testing, but specific details (e.g., sample sizes, specific test protocols) are not provided in this excerpt.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).